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Completed

NCT Number: NCT06349057

The Effect of the Anticholinergic Burden Following Elective Coronary Artery Surgery

Anticholinergic drugs are common in older adults and linked to cognitive decline, frailty, longer hospital stay, and higher mortality. This cumulative burden, often increased by anesthetics and analgesics, may worsen during surgery. The study evaluates whether reducing perioperative anticholinergic load improves recovery after cardiac surgery.

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Key information

Conditions

Postoperative Recovery Length of Hospital Stay Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aslihan Aykut

Ankara, çankaya, 06800, Turkey (Türkiye)

About this study

Anticholinergic agents are frequently prescribed in older adults and have been linked to negative outcomes such as cognitive decline, frailty, extended hospitalization, and increased mortality. The cumulative exposure, referred to as anticholinergic burden, may be exacerbated during the perioperative period due to anesthetic and analgesic use. This trial explores whether minimizing perioperative anticholinergic burden can improve postoperative recovery following cardiac surgery. In this prospective, randomized controlled study, 120 patients aged 60 years or older undergoing isolated coronary artery bypass grafting with a preoperative Anticholinergic Cognitive Burden score of ≥3 were included. Participants were assigned either to standard perioperative care involving anesthetic and analgesic agents with anticholinergic activity (Group Standard) or to a deprescribing protocol excluding all anticholinergic drugs intraoperatively and postoperatively (Group Deprescribing). The primary endpoints were functional recovery assessed at 90 days using the Katz Index and Clinical Frailty Scale. Secondary endpoints comprised hospital length of stay, 90-day incidence of cardiac and pulmonary complications, intensive care Unit stay, duration of mechanical ventilation, additional complications, and 90-day mortality. The Wilcoxon signed-rank test was used for paired comparisons of Katz and frailty scores, while multivariate logistic regression was applied to identify independent predictors of postoperative cardiac complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing elective coronary artery bypass surgery
  • Patients with high anticholinergic burden

Exclusion criteria

  • All other procedures except isolated coronary bypass surgery
  • Patients with low anticholinergic burden
  • Patients whose records cannot be accessed through the data system

Treatment and study plan

reducing anticholinergic burden

Drug

In the intraoperative and postoperative periods instead of drugs with high anticholinergic burden; drugs with low burden will be preferred.

Other names: not reducing anticholinergic burden, routine care

Primary outcomes

  1. Katz Index of Independence in Activities of Daily Living and Clinical Frailty Scale (CFS)

    Time frame: Postoperative day 90

    The Katz Index of Independence in Activities of Daily Living evaluates a patient's ability to perform six basic functions: bathing, dressing, toileting, transferring, continence, and feeding. Each activity is scored as either "independent" (1 point) or "dependent" (0 points). The total score reflects the patient's overall level of functional independence.

    The Clinical Frailty Scale (CFS) is a validated 9-point tool used to assess a patient's baseline frailty status. It evaluates physical fitness, comorbidity burden, functional dependence, and overall health status. Scores range from 1 (Very Fit) to 9 (Terminally Ill). Higher scores indicate greater frailty and worse baseline physiological reserve.

Secondary outcomes

  1. Intensive Care Unit Length of Stay (days)

    Time frame: From postoperative ICU admission until ICU discharge (typically within 1-3 days).

    The duration of stay in the intensive care unit, measured in days, from ICU admission after surgery until ICU discharge.

  2. Duration of Mechanical Ventilation (hours)

    Time frame: From the end of surgery to extubation

    The duration of postoperative mechanical ventilation, measured in hours, from end of surgery until successful extubation.

  3. other postoperative complications

    Time frame: From completion of surgery to postoperative day 90

    Occurrence of postoperative complications within 90 days after surgery, including neurological (stroke, transient ischemic attack, seizures), renal (acute kidney injury, need for renal replacement therapy, chronic renal failure), and infectious complications (pneumonia, mediastinitis, meningitis, urinary tract infection, wound infection, catheter-related sepsis), as well as delirium.

  4. all-cause mortality

    Time frame: From completion of surgery to postoperative day 90

    All-cause mortality occurring within 90 days after surgery.

  5. Change in Katz Index of Independence in Activities of Daily Living From Baseline

    Time frame: Baseline (preoperative) to postoperative day 90

    The change in Katz Index score will be calculated as the postoperative day 90 score minus the preoperative baseline score. The Katz Index ranges from 0 (highly dependent) to 6 (independent). Higher scores indicate better functional independence.

  6. Postoperative major cardiac complications

    Time frame: From completion of surgery to postoperative day 90

    Incidence of major postoperative cardiac complications, including cardiac arrest, myocardial infarction, arrhythmia, and aortic dissection.

  7. Hospital length of stay (days)

    Time frame: From hospital admission for surgery until hospital discharge (typically within 5-10 days).

    Duration of postoperative hospital stay, measured in days, from admission to the hospital after surgery until hospital discharge.

  8. Incidence of major pulmonary complications

    Time frame: From completion of surgery to postoperative day 90

    Major postoperative pulmonary complications, including pneumothorax, pleural effusion, pulmonary embolism, and acute respiratory distress syndrome (ARDS).

  9. Change in Clinical Frailty Scale (CFS) from baseline

    Time frame: Baseline (preoperative) to postoperative day 90

    Change in Clinical Frailty Scale (CFS) score from preoperative baseline to postoperative day 90.

    The CFS is a nine-point scale assessing mobility, energy, physical activity, and overall functional health:

    • = Very Fit
    • = Well
    • = Managing Well
    • = Vulnerable
    • = Mildly Frail
    • = Moderately Frail
    • = Severely Frail
    • = Very Severely Frail
    • = Terminally Ill Higher scores indicate greater frailty.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Anticholinergic Burden as a Modifiable Risk Factor in Cardiac Surgery: Evidence From a Randomized Controlled Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 5, 2024
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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